Safety Study of HPP593 in Subjects During and After Limb Immobilization

A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01524406

Enrollment

Registered

2012-02-02

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypodynamia, Muscle Atrophy

Keywords

Muscle Atrophy

Brief summary

This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.

Interventions

DRUGHPP593

Oral, twice a day.

DRUGPlacebo

Oral, twice a day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

30 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Non-smoking. * Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results. * Not restricted to a wheel-chair or confined to a bed. * Weight ≥ 50.0 kg. * BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.

Exclusion criteria

* Any of the following abnormalities at Screening Visit and Baseline: * Fasting glucose \> 110 mg/dL (Screening visit only). * Serum creatinine \> 1.5 mg/dL. If serum creatinine is \>1.5 mg/dL and creatinine clearance is \>60 mL/min, the subject need not be excluded * Troponin I level above the upper limit of normal (ULN) * Liver function tests (LFTs) \> 1.5x ULN * Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension) * Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit. * Has received HPP593 in a previous clinical trial. * Smoking within 6 month prior to Day -1. * Michigan Alcohol Screening Test score greater than 2.

Design outcomes

Primary

Measure	Time frame	Description
Safety Evaluation	Baseline to Day 42	Number and severity of adverse events across trial period

Secondary

Measure	Time frame
Change in Muscle Strength	Day 1 to Day 42
Changes on Muscle Related Biomarkers	Day 1 to Day 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026